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Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study (TMS/DEP)

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TRD stage I Thase-Rush
  • HDRS + or = 18
  • Patients age 18 to 70 years.
  • Negative pregnancy test and contraception for women.
  • Informed Consent

Exclusion Criteria:

  • Patient was treated with mood stabilizer in the previous week
  • Other disorder on axis I of the DSM IV than depressive disorder.
  • Patient with an addiction problem other than tobacco and caféine
  • antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
  • Previous history of head trauma the previous two years.
  • intracranial hypertension.
  • not affiliated to the social security Patient
  • patient under constraint hospitalisation
  • Under legal protection measure

Sites / Locations

  • Unité de Recherche CliniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

repetitive transcranial magnetic stimulation

Sham comparator

Arm Description

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks

Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks

Outcomes

Primary Outcome Measures

'Hamilton depression rating scale (HDRS)
The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD). The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2015
Last Updated
March 3, 2015
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT02383693
Brief Title
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Acronym
TMS/DEP
Official Title
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
number of center : 1 duration of study : 24 months recruitement time : 23 months Aim :Principal Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients. Secondary Evaluate the impact of rTMS on cognitive functions.
Detailed Description
The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
Repetitive Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
'Hamilton depression rating scale (HDRS)
Description
The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD). The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.
Time Frame
one years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TRD stage I Thase-Rush HDRS + or = 18 Patients age 18 to 70 years. Negative pregnancy test and contraception for women. Informed Consent Exclusion Criteria: Patient was treated with mood stabilizer in the previous week Other disorder on axis I of the DSM IV than depressive disorder. Patient with an addiction problem other than tobacco and caféine antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker Previous history of head trauma the previous two years. intracranial hypertension. not affiliated to the social security Patient patient under constraint hospitalisation Under legal protection measure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique januel, MD.Phd
Phone
0143093232
Email
domjanuel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene BENADHIRA, MD
Organizational Affiliation
E.P.S ville Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Recherche Clinique
City
Neuilly Sur Marne
State/Province
Île de France
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arezki OURRAD, BIOLOGISTE
Phone
0143093232

12. IPD Sharing Statement

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Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

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